AccessGUDID - DEVICE: RECIVER DISH (04953170305689)

GUDID

Device Identifier (DI) Information

Brand Name: RECIVER DISH
Version or Model: MAJ-1868
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170305689
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-1868 ScopeGuide Receiver Dish

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64660	Gastrointestinal catheter/endoscope tracking system sensor, bedside	An external, electrically-powered component of a gastrointestinal catheter/endoscope tracking system designed to receive and process electromagnetic (EM) field data produced by an appropriate catheter/endoscope in situ for real-time visualization of the catheter/endoscope position within the gastrointestinal tract. It is typically a flat panel designed to be mounted next to the patient to transcutaneously receive the specific EM pulses generated by the catheter/endoscope and transmit the data to an appropriate processing unit/monitor (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103312	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12e041cd-3d85-43a3-93b4-69534267d373
Public Version Date: April 22, 2024
Public Version Number: 7
DI Record Publish Date: September 21, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)401-1086
Email: xx@xx.xx

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